Pfizer says its vaccine is safe for children aged between 5 and 11
WASHINGTON: Pfizer Inc. and partner BioNTech SE said their Covid-19 vaccine was safe and produced strong antibody responses in children ages 5 to 11 in a large-scale trial, findings that could pave the way to begin vaccinating grade-school kids within months.
The long-awaited results offer one of the first looks at how well a Covid vaccine could work for younger children. Pressure to immunise kids has been on the climb in the US, where a new school year has started just as the delta variant is fuelling a surge in cases.
In a trial with 2,268 participants, two shots of a 10 microgram dose -- one-third the adult shot -- produced antibody levels comparable to those seen in a trial of 16-to-25-year-olds who got the adult dose, the companies said, with similar side effects.
Pfizer and BioNTech said they plan to submit the data as part of a near-term request for an emergency-use authorization from the US Food and Drug Administration, and to share it with regulators in Europe as well.
“Since July, paediatric cases of Covid-19 have risen by about 240% in the US, underscoring the public health need for vaccination,” Pfizer chief executive Albert Bourla said in a news release. “These trial results provide a strong foundation for seeking authorisation of our vaccine for children 5 to 11 years old, and we plan to submit them to the FDA and other regulators with urgency,” Bourla added.
An outside expert said scientists want to see more details but called the report encouraging.
“These topline results are very good news,” said Dr Jesse Goodman of Georgetown University, a former FDA vaccine chief. The level of immune response Pfizer reported “appears likely to be protective”.
Many Western countries so far have vaccinated no younger than age 12, awaiting evidence of what’s the right dose and that it works safely. Cuba last week began immunising children as young as 2 with its homegrown vaccines and Chinese regulators have cleared two of its brands down to age 3.
While kids are at lower risk of severe illness or death than older people, more than 5 million children in the US have tested positive for Covid-19 since the pandemic began and at least 460 have died, according to the American Academy of Pediatrics. Cases in children have risen as the delta variant swept through the country.
The Pfizer study still is ongoing, and there haven’t yet been enough Covid-19 cases to compare rates between the vaccinated and those given a placebo — something that might offer additional evidence.
The study isn’t large enough to detect any extremely rare side effects, such as the heart inflammation that sometimes occurs after the second dose, mostly in young men. The FDA’s Marks said the paediatric studies should be large enough to rule out any higher risk to young children. Pfizer’s senior vice president Dr. Bill Gruber said that once the vaccine is authorised for younger children, they’ll be carefully monitored for rare risks just like everyone else.
A second US vaccine maker, Moderna, also is studying its shots in elementary school-aged children. Pfizer and Moderna are studying even younger tots as well, down to 6-month-olds. Results are expected later in the year.
FDA acting commissioner Janet Woodcock said that once the agency receives the application, its process for determining if the vaccine is safe and effective for children in the younger age group includes verifying the manufacturing processes for the lower concentrations of the shots and any study of its safety.